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In Brief This Week: PerkinElmer, OraSure Technologies, LabCorp, Molzym, UniLabs, and More

NEW YORK – PerkinElmer this week disclosed that it initiated a restructuring plan during the first quarter of 2021 that is expected to reduce its workforce by 77 employees. The restructuring plan is "intended to realign resources to emphasize growth initiatives and integrate new acquisitions," the Waltham, Massachusetts-based firm said in its Form 10-Q filed with the US Securities and Exchange Commission, adding that the plan is expected to result in initial restructuring or contract termination charges of about $5.6 million, including $3.9 million in the Discovery & Analytical Solutions segment and $1.6 million in the Diagnostics segment.

The firm also said that it acquired an undisclosed asset in Q1 for $2.5 million. That was in addition to the acquisition of Oxford Immunotec for $591 million, which closed in March.

Insignia Federal Group said this week that it has been selected, along with Building Healthy Online Communities, Emory University, Keymind, and OraSure Technologies, by the US Centers for Disease Control and Prevention to distribute 100,000 HIV self-tests.

The distribution is part of an effort by the CDC to increase HIV testing among gay and bisexual men, transgender women, and racial and ethnic minorities, and contribute to the Ending the HIV Epidemic in the US initiative. OraSure's OraQuick In-Home HIV tests, which allow an individual to detect antibodies to both HIV-1 and HIV-2 with an oral swab, will be distributed as part of the initiative. The test provides results in 20 minutes and is the only oral fluid, rapid, over-the-counter HIV test approved in the US.

The US Food and Drug Administration this week revised its Emergency Use Authorization for Laboratory Corporation of America's Pixel by Labcorp COVID-19 PCR Test Home Collection Kit to allow its use for children and adolescents at least 2 years of age when the kit is purchased by a parent or guardian. Individuals 14 to 17 years old can self-collect samples with the kit with adult supervision, while children 2 to 13 years old will need adult assistance for sample collection, Labcorp said. The over-the-counter version of the kit originally received EUA in December.

The US Court of Appeals for the Federal Circuit this week denied Pacific Biosciences' requests for a new trial in a case that led a jury to invalidate four of the company's patents. In March 2020, a jury found that Oxford Nanopore Technologies infringed three patents held by Pacific Biosciences but also found those patents to be invalid. PacBio had asked the US District Court for the District of Delaware for a new trial but was denied, and had then appealed.

"Oxford Nanopore is pleased with this outcome, which it anticipates effectively ends a series of frivolous disputes perpetrated by PacBio," the company said in a statement. "We are reviewing the opinion and will determine next steps," a PacBio spokesperson said in an email, noting that the decision has "no impact" on the company's ability to provide HiFi sequencing.

Molzym said this week that the US Food and Drug Administration has granted Breakthrough Device Designation to its molecular diagnostic test system as an adjunct to the current standard of care for the diagnosis of bloodstream infections including sepsis, joint and implant infections, infective endocarditis, and bacterial meningitis.

Molzym's molecular diagnostic test system, has a total time-to-result of seven hours, and provides enrichment and extraction of microbial DNA directly from samples, the company said. Its DNA-free reagents and consumables detect the presence of bacteria and fungi. Positive PCR results are processed through Sanger sequencing to identify the specific microorganisms and assist physicians with clinical decisions.

Centogene said this week that it has extended the Rostock International Parkinson's Disease study, which focuses on the role of genetics in the disease. The study, which screens for mutations in LRRK2 and other Parkinson-associated genes, has already tested 10,000 participants and now aims to recruit and test an additional 2,500 patients by the end of 2021. It will focus on 40 sites in 11 countries, including Brazil, Germany, Spain, and the US.

Unilabs announced this week that it is ramping up PCR pooling testing for SARS-CoV-2 in Europe. Pooling is available in Switzerland and Slovakia and is currently being rolled out to other countries in the firm’s 16-country network. The company also said schools and businesses are continuing to enroll in its Unilabs Protect program to receive pooled PCR testing. Unilabs has the capacity to perform 500,000 tests per week and said its capacity is continuing to grow.

908 Devices, a Boston-based developer of miniature mass spectrometers, said this week that its first quarter revenue increased 39 percent to $5.5 million from $4.0 million a year ago, driven primarily by an increase in sales of its MX908 and Rebel instruments and strong recurring revenues. The company said it placed 66 devices in Q1, double that of a year ago and increasing its installed base to 1,427 devices. The company reported a Q1 net loss of $6.1 million, or $.22 per share, compared to a net loss of $3.0 million, or $.60 per share, a year ago.

During the quarter, 908 Devices announced a collaboration with Bio-Techne to develop an extended workflow for protein characterization, bolstering its life sciences portfolio. The firm finished the quarter with $149 million in cash and cash equivalents and maintained full-year 2021 revenue guidance of $38 million to $40 million, representing 41 percent to 49 percent year-over-year growth.

Epigenomics this week reported that its first quarter product revenues decreased 56 percent to €106,000 ($128,738) from €239,000 a year ago as many patients in the US and Europe postponed cancer screenings due to the COVID-19 pandemic. The company reported a Q1 net loss of €1.2 million, or €.20 per share, compared to €3.0 million, or €.55 per share, a year ago. Epigenomics' R&D costs fell 54 percent to €737,000 from €1.6 million, while its SG&A costs dropped 20 percent to €1.6 million from €2.0 million. The company finished the quarter with €7.4 million in cash, cash equivalents, and marketable securities.

Ellume said this week that it has established a US manufacturing facility in Frederick, Maryland. The 180,000-square-foot site will have the capacity to manufacture 19 million Ellume COVID-19 Home Tests per month. The firm expects to provide 8.5 million tests to the US government by the end of the year and is now recruiting for 1,500 new positions. Ellume was awarded approximately $232 million from the US Department of Defense and Department of Health and Human Services to accelerate production of its US Food and Drug Administration Emergency Use Authorized home-use antigen test. The firm is currently supplying US customers with assays manufactured in its facility in Brisbane, Australia, in partnership with the NIH’s Rapid Acceleration of Diagnostics initiative.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.